She addressed the significant changes introduced in the revised version, which brought more stringent obligations for the pharmaceutical industry. Dilek explained the reasons behind the revision, including the fact that Annex 1 had not been updated since 2008, despite significant advancements in manufacturing technologies. The new version had expanded considerably, now encompassing 58 pages compared to just 16 in the previous edition. A key highlight of the revision was its emphasis on risk management, reflecting the evolving needs of the industry. Dilek guided the audience through the most critical aspects of Annex 1, ensuring an understanding of the essential changes and their implications for cleanroom design and operation in the pharmaceutical sector.
Dilek Sunar…
…a trailblazer in her field, has dedicated her career to pioneering firsts across the pharmaceutical and cleanroom industries. She graduated from Istanbul University’s Faculty of Pharmacy in 1983 and began her professional journey as a sterile production supervisor at Eczacıbaşı Pharmaceuticals. In 1984, as Turkey embarked on implementing GMP practices, she became the country’s first GMP specialist, marking the beginning of GMP activities in Turkey. Dilek later contributed significantly to the establishment and design of Eczacıbaşı’s Lüleburgaz facilities. In 1998, she co-founded Turkey’s first independent validation company, I.C.C.E.-Istanbul, which later earned TÜRKAK accreditation in 2007 as the first third-party accredited validation company in the country. Dilek is also the co-founder of Academia Life Sciences Center, where she and her team provide expert consultancy and training on GXP regulations. As the chairman of the Turkish Clean Room Technologies Association, she is a recognized expert in ISO 14644-3 standards and continues to shape the future of cleanroom technologies through education and innovation.